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OpenTrials
Completed

NCT Number: NCT05671562

The Effect of Lycopene on Sperm Quality in Men Attending Fertility Clinic

The goal of this clinical trial is to test whether lycopene (an antioxidant found in cooked tomatoes) will improve the number of swimming sperm in the ejaculates of men with low total motile sperm count.

Participants will take either lycopene capsules or identical capsules containing no lycopene for 12 weeks. We will analyse the quality of their semen before and after taking the capsules, and compare the results.

Hypothesis: Supplementation with lycopene will improve testicular function (semen quality) in males with low total motile sperm count (TMSC).

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Jessop Fertility

Sheffield, United Kingdom

About this study

Impaired testicular function contributes to around 50% of heterosexual infertility and is often characterized by a low total motile sperm count. Evidence suggests that one cause of low total motile sperm count is oxidative stress within the ejaculate, where harmful oxygen species damage the sperm. Antioxidants to combat oxidative stress within the ejaculate have been proposed as a method of increasing the total motile sperm count. Lycopene is a powerful antioxidant found abundantly in cooked tomatoes and has been shown to improve testicular function in a healthy population. This double blinded randomised controlled trial aims to investigate whether lycopene can improve testicular output in participants with a low motile sperm count. Semen analysis will be carried out before and after the intervention. The intervention is a commercially available lycopene capsule or an identical placebo.

Hypothesis: Supplementation with lactolycopene will improve testicular function (semen quality) in males with low total motile sperm count (TMSC).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males aged 18 - 50 years of age
  • Attending the Fertility Clinic at the Jessop Wing, (Sheffield Teaching Hospitals).
  • Found to have poor testicular function as evidenced by a low motile sperm count (<20 million motile sperm per ejaculate).
  • Willing to comply with the study procedures and provide informed consent.

Exclusion criteria

  • Participants who report allergy to tomatoes, whey, soy.
  • Men with previous testicular surgery or a current or previous diagnosis of cancer.
  • Men found to have normal sperm parameters.
  • Known infection with hepatitis or HIV.
  • Men with azoospermia

Treatment and study plan

lycopene

Dietary Supplement

Capsule containing lycopene 7mg x 2 daily for 12 weeks

Placebo

Dietary Supplement

Capsule containing inactive substance 7mg x 2 daily for 12 weeks

Primary outcomes

  1. Total motile sperm count

    Time frame: Change from Baseline total motile sperm count at 12 weeks

    Number of swimming sperm in the total ejaculate

Secondary outcomes

  1. Sperm motility

    Time frame: Change from Baseline sperm motility at 12 weeks

    % of swimming sperm

  2. Sperm concentration

    Time frame: Change from Baseline sperm concentration at 12 weeks

    Number of sperm per ml of ejaculate

  3. Sperm morphology

    Time frame: Change from Baseline sperm morphology at 12 weeks

    Appearance of sperm

  4. Sperm DNA fragmentation

    Time frame: Change from Baseline sperm DNA fragmentation at 12 weeks

    % of sperm with fragmented DNA

  5. Oxidative reductive potential of semen

    Time frame: Change from Baseline semen oxidative reductive potential at 12 weeks

    To compare level of oxidants and antioxidants within the sample

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • Health Education England, Wessex
  • Manchester Metropolitan University
  • University of Sheffield

Registry information

Official study title

A Randomised Placebo-controlled Trial to Investigate the Effect of Lactolycopene on Sperm Quality in Men With a Low Total Motile Sperm Count: a Pilot Study.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 4, 2023
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.